Changes in 21 CFR Part 11 Subpart C, Electronic Signatures

Update on recent changes in 21 CFR (Code of Federal Regulations)#

On 02nd March 2023; The text of § 11.100 General requirements of Subpart C Electronic Signatures

Title 21 [Food and Drugs]

Chapter I [Food and Drug Administration, Department of Health and Human Services]

Subchapter A [General]

Part 11 [Electronic Records; Electronic Signatures]

Subpart C [Electronic Signatures]

§ 11.100 [General requirements]

Comparing the CFR in effect on 02-March-2023 to what was previously in effect on 01-March-2023, Changes are highlighted in the text below.

§ 11.100 General requirements.

(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.

(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature , to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857 and submitted in electronic or paper form. Information on where to submit the certification can be found on FDA’s web page on Letters of Non-Repudiation Agreement.

(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature.

Change [62 FR 13464, Mar. 20, 1997, as amended at 88 FR 13018, Mar. 2, 2023]